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METHOD DEVELOPMENT AND VALIDATION FOR QUANTIFICATION OF BENZENE AND ETHYLENE DICHLORIDE IN BACLOFEN DRUG SUBSTANCE BY GC-HS USING FID DETECTOR

*Hari Darshan Singh, *Dr. Rahul Kumar


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    <subfield code="a">METHOD DEVELOPMENT AND VALIDATION FOR QUANTIFICATION OF BENZENE AND ETHYLENE DICHLORIDE IN BACLOFEN DRUG SUBSTANCE BY GC-HS USING FID DETECTOR</subfield>
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    <subfield code="a">&lt;p&gt;&lt;em&gt;A proficient GC-HS method was developed for quantification of Benzene and Ethylene Dichloride in Baclofen drug substance with flame ionization detector (FID) using column DB-1, (30m length X 0.32mm diameter) 5&amp;micro;m film thickness, Part No.: 123-1035, Make: Agilent.&amp;nbsp; Nitrogen is used as Carrier gas at with flow rate of 1.0 ml/minute. The proposed method was validated for System suitability, Specificity, Linearity, LOD and LOQ determination, Recovery, Precision, Range and Robustness. All the parameters were found within the acceptable limits. Linearity of Benzene and Ethylene Dichloride is in the range of LOQ to 150%. The established methodology was commercially useful, specific, accurate, precise and suitable for the analysis of Benzene and Ethylene Dichloride in Baclofen drug substance. &lt;/em&gt;&lt;/p&gt;

&lt;p&gt;&lt;strong&gt;&lt;em&gt;Keywords&lt;/em&gt;&lt;/strong&gt;&lt;em&gt;: Gas Chromatography with Head space (GC-HS), Guideline for Residual Solvents Q3C(R8) and Method Validation, Baclofen drug substance, Benzene and Ethylene Dichloride&lt;/em&gt;&lt;/p&gt;</subfield>
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